FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS (RA), IN COMBINATION WITH METHOTREXATE (MTX)
WHAT OCCUPIES YOUR MIND?
Think SIMPONI ARIA®
- Significant improvement in signs and symptoms1,2
— ACR20 response at Week 14 (primary endpoint): 59% (231/395) of patients receiving SIMPONI ARIA® + MTX achieved ACR20 response vs 25% (49/197) of patients receiving placebo + MTX (P<0.001)
— Rapid ACR20 response at Week 2: 33% (131/395) of patients receiving SIMPONI ARIA® + MTX achieved ACR20 response vs 12% (23/197) of patients receiving placebo + MTX (P<0.001)
- Significant inhibition of progression of structural damage1,3
— At Week 24, the mean change from baseline in total vdH-S* score was 0.03 for patients receiving
SIMPONI ARIA® + MTX (n=395) vs 1.09 for patients receiving placebo + MTX (n=197) (P<0.001)
The only anti-TNF IV therapy without a biosimilar for moderately to severely active RA. SIMPONI ARIA® may help maintain prescribing control.
Dosing and Administration
GIVEN ONCE EVERY 8 WEEKS
AFTER STARTER DOSES1
AS FEW AS
TIMES A YEAR
AFTER STARTER DOSES
AT WEEKS 0 AND 41
- “Efficient” is defined as the total amount of time required to administer SIMPONI ARIA®
- 2 mg/kg administered once every 8 weeks, after starter doses at Weeks 0 and 41
Janssen Offers Support to Ease Your Mind
- First-line biologic access is available nationwide for 75% of commercially insured patients3†‡
- First-line biologic access is available nationwide for 100% of Medicare Part B patients3†
- Eligible commercially insured patients pay just
Contract Purchase Program
- Established discount program for physician practices
- Janssen Immunology Specialists
- Janssen Area Business Specialists
- Health Policy and Advocacy Specialists
Study design: GO-FURTHERTM was a global, multicenter, randomized, double-blind, placebo-controlled study in 592 adult patients who had moderately to severely active RA despite a stable dose of MTX (15-25 mg/week for ≥4 weeks) for ≥3 months and who had not been previously treated with an anti-TNF agent. Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total), rheumatoid factor (RF) positive and/or anti-cyclic citrullinated peptide (anti-CCP) antibody positive, and C-reactive protein (CRP) ≥1.0 mg/dL. Patients were randomized to receive SIMPONI ARIA® 2 mg/kg + MTX (n=395) or placebo + MTX (n=197) as a 30-minute IV infusion at Weeks 0 and 4, and then q8 weeks through Week 100. At Week 16, patients in the placebo + MTX group with <10% improvement from baseline in both swollen joint count and tender joint count began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 16 and 20, followed by maintenance infusions q8 weeks in a blinded manner. At Week 24, all patients remaining in the placebo + MTX group began receiving SIMPONI ARIA® 2 mg/kg beginning with an induction regimen at Weeks 24 and 28, followed by maintenance infusions q8 weeks in a blinded manner. All patients continued to receive MTX. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.
*vdH-S=van der Heijde Modified Sharp score. The total modified vdH-S score (0-448) is a composite score of structural damage that measures the number and size of joint erosions and the degree of joint space narrowing in the hands and feet.
†First-line biologic: Brand-name drug that does not require trial on another biologic product prior to utilization.
‡Data as of July 2016. Based on an analysis of major insurers that includes approximately 90% of commercially insured patients.
§The Janssen CarePath rebate expires after $20,000 maximum annual benefit or 12 months from first eligible date of service, whichever comes first. Program is not available to individuals enrolled in federal or state subsidized healthcare programs that cover prescription drugs, including Medicare, such as the Medicare Part D prescription drug benefit, Medicaid, TRICARE®, or any other federal or state healthcare plan, including pharmaceutical assistance programs.
References: 1. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Weinblatt ME, Bingham CO III, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72:381-389. 3. Data on file. Janssen Biotech, Inc.
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